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Medical device cyber security information for users v1.2
Consumers, health professionals, small business operators and large scale service providers
Category
Guidance Document
Organisation
TGA
Type
Standard
Version
1.2
Access
Open
Status
Active
Updated
Nov-22
This document describes cyber security practices and protocols for the medical device sector and aims to help medical device users manage cyber security risk.
Medical device patient information leaflets and implant cards (including acceptance of Implementation Plans) v1.9
Category
Guidance Document
Organisation
TGA
Type
Standard
Version
1.9
Access
Open
Status
Active
Created
Oct-22
Updated
May-23
This document aims to help manufacturers and sponsors understand the legislative requirements for patient information materials, such as patient implant cards and patient information leaflets, and how to comply with these requirements.
Medical device patient information materials: a fact sheet for health professionals
Category
Supplementary Resource
Organisation
TGA
Type
Standard
Access
Open
Status
Active
Updated
May-23
This fact sheet for health professionals discusses providing patients with information about their medical devices. It discusses who is responsible for providing patient information leaflets (PILs) and patient implant cards (PICs) to patients, and when they should be supplied.
Regulation of software based medical devices
Category
Guidance Document
Organisation
TGA
Type
Standard
Access
Open
Status
Active
Updated
Jul-24
This document provides information on the regulation in Australia for software and apps which meet the legislated definition of a medical device. It helps manufacturers and sponsors understand how the Therapeutic Goods Administration (TGA) interprets requirements, and how they can comply with the regulations.
Regulatory basics on medical devices for health practitioners v1.0
Category
Guidance Document
Organisation
TGA
Type
Standard
Version
V 1.0
Access
Open
Status
Active
Created
Mar-24
This guidance is for Australian health practitioners who manufacture, supply and use medical devices. It helps them identify whether their devices are regulated by the Therapeutic Goods Administration (TGA) and it also advises how to comply with the requirements of the therapeutic goods legislation.
Standard for serialisation and data matrix codes on medicines v1.0
Guidance for TGO 106
Category
Supplementary Resource
Organisation
TGA
Type
Standard
Version
V 1.0
Access
Open
Status
Active
Created
Mar-21
This guidance is for sponsors and manufacturers supplying medicines in Australia that are serialised or have data matrix codes. It describes the requirements in the Therapeutic Goods (Medicines – Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2021.
ICD API Authentication
Category
Supplementary Resource
Organisation
WHO
Type
Standard
Access
Open
Status
Active
This resource lays out the steps to use the ICD APIs, which allow programmatic access to the International Classification of Diseases (ICD).
ICD API Samples GitHub repository
Category
Supplementary Resource
Organisation
WHO
Type
Standard
Access
Open
Status
Active
This GitHub repository contains samples for ICD API and other related repositories.
ICD-10 User Guide
Category
User guide
Organisation
WHO
Type
Standard
Access
Open
Status
Active
This user guide contains information on how to use the International Statistical Classification of Diseases and Related Health Problems 10th revision (ICD 10) online application.
ICD-10 Version:2019
Category
Specification
Organisation
WHO
Type
Standard
Version
2019
Access
Open
Status
Active
The International Statistical Classification of Diseases and Related Health Problems 10th revision (ICD-10 Version:2019) is part of the WHO Family of International Classifications (WHO-FIC) that allows all healthcare workers (and patients) to communicate using one (technical) language.
ICD-10 International statistical classification of diseases and related health problems. 10th revision. Volume 2 Instruction manual v6 2019
Category
Guidance Document
Organisation
WHO
Type
Standard
Version
43617
Access
Open
Status
Active
Created
2019
This instruction manual for the tenth revision of the International Statistical
Classification of Diseases and Related Health Problems (ICD-10) contains
guidelines for recording and coding, and instructions on practical aspects of the ICD’s use. However, users must also undergo formal training in the use of the ICD.
ICD-11 for Mortality and Morbidity Statistics
Category
Specification
Organisation
WHO
Type
Standard
Access
Open
Status
Active
Created
Jan-24
This webpage allows the user to search the ICD-11 mortality and morbidity statistics on diseases and related health problems for the condition/s they are interested in.
ICD-11 Browser User Guide
Category
User guide
Organisation
WHO
Type
Standard
Access
Open
Status
Active
ICD-11 Browser is a website that allows users to see the content of the International Statistical Classification of Diseases and Related Health Problems 11th revision (ICD-11). This user guide provides details on how to search the ICD-11 efficiently.
ICD-11 Coding Tool
Mortality and Morbidity Statistics (MMS)
Category
Supplementary Resource
Organisation
WHO
Type
Standard
Access
Open
Status
Active
Created
Jan-24
This coding tool allows the user to search for specific diseases or related health problems in the International Statistical Classification of Diseases and Related Health Problems 11th revision (ICD-11) to obtain the ICD-11 code for the condition.
ICD-11 Implementation or Transition Guide v1.05
Category
Implementation Guide
Organisation
WHO
Type
Standard
Version
1.05
Access
Open
Status
Active
Created
2019
This guide is a part of the ICD-11 (International Statistical Classification of Diseases and Related Health Problems 11th revision) implementation package. The guide supports decisionmakers in planning the implementation of, or transition to, the new ICD-11 in their jurisdictions.
ICD-11 Reference Guide
International Classification of Diseases for Mortality and Morbidity Statistics 11th revision
Category
Guidance Document
Organisation
WHO
Type
Standard
Access
Open
Status
Active
Created
2022
The ICD-11 is the latest (11th) revision of the International Classification of Diseases (ICD). This reference guide presents an introduction to ICD-11 and provides guidance on its use.
ICD-API v2
Category
Specification
Organisation
WHO
Type
Standard
Version
2
Access
Open
Status
Active
Created
2019
Updated
Jan-24
ICD API is an HTTP-based REST API that allows programmatic access to the International Classification of Diseases (ICD). This document and the API-Reference is for software developers who would like to consume the ICD-API in their software.
Environmental Sustainability and Climate Resilience Healthcare Module
Draft version
Category
Supplementary Resource
Organisation
ACSQHC
ID
D23-51832
Type
Standard
Access
Open
Status
Draft
Created
Nov-23
The document provides a framework of environmental sustainability and climate resilience actions that use a health service organisation’s existing governance, safety and quality systems.
An Introduction to Artificial Intelligence
Category
Guidance Document
Organisation
Australian Signals Directorate's Australian Cyber Security Centre (ASD's ACSC)
Type
Standard
Access
Open
Status
Active
Created
Nov-23
This document provides readers with an understanding of what artificial intelligence (AI) is and how it may impact the digital systems and services they use.
An Introduction to Securing Smart Places
Category
Guidance Document
Organisation
Australian Signals Directorate's Australian Cyber Security Centre (ASD's ACSC)
Type
Standard
Access
Open
Status
Active
Created
Nov-22
Smart places are places that use smart technology (IT)-enabled systems to provide enhanced services to citizens. This document explores the key security risks of smart places and ways to mitigate risk.
Engaging with Artificial Intelligence
Category
Guidance Document
Organisation
Australian Signals Directorate's Australian Cyber Security Centre (ASD's ACSC)
Type
Standard
Access
Open
Status
Active
Created
Jan-24
This document provides organisations with guidance on how to use artificial intelligence (AI) systems securely.
IoT Secure-by-Design Guidance for Manufacturers
Category
Guidance Document
Organisation
Australian Signals Directorate's Australian Cyber Security Centre (ASD's ACSC)
Type
Standard
Access
Open
Status
Active
Created
Sep-20
This document provides cyber security guidance for manufacturers of Internet of Things (IoT) devices, such as drones, security cameras, smart televisions, solar inverters and other ‘smart’ devices.
Strategies to Mitigate Cyber Security Incidents – Mitigation Details
Category
Guidance Document
Organisation
Australian Signals Directorate's Australian Cyber Security Centre (ASD's ACSC)
Type
Standard
Access
Open
Status
Active
Created
Feb-10
Updated
Feb-17
This document helps organisations mitigate cyber security incidents caused by targeted cyber intrusions, ransomware, malicious insiders, business email compromise and threats to industrial control systems.
GS1 Architectural Principles
Category
Specification
Organisation
GS1
Type
Standard
Version
4
Access
Open
Status
Active
Created
Jun-20
This document sets out the architectural principles that underpin the GS1 system.
GS1 System Architecture
Category
Specification
Organisation
GS1
Type
Standard
Version
11.1
Access
Open
Status
Active
Created
Mar-23
The GS1 system is the collection of standards, guidelines, solutions, and services created by the GS1 community. This document defines and describes the architecture of the GS1 system of standards.
GS1 Pharmaceutical Clinical Trial Electronic Messaging Standard Implementation Guideline
Category
Implementation Guide
Organisation
GS1
Type
Standard
Version
1.2
Access
Open
Status
Active
Created
Jun-23
This guideline details the best-practice approach to implementing GS1 standards for electronic messaging in the pharmaceutical clinical trial supply chain.
GS1 Pharmaceutical Image Implementation Guideline
Category
Implementation Guide
Organisation
GS1
Type
Standard
Version
1
Access
Open
Status
Active
Created
Jun-17
This document provides a method of image naming for pharmaceutical products to increase efficiencies and minimise costs.
GS1 Product Image Specification Standard
Category
Standard
Organisation
GS1
Type
Standard
Version
4.4
Access
Open
Status
Active
Created
Apr-24
This standard establishes rules for the storage of digital images associated with products. It covers images such as barcodes and labels as well as photographic and rendered product images.
GS1 Third-Party Data Exchange in Healthcare – Implementation guide
Category
Implementation Guide
Organisation
GS1
Type
Standard
Version
2
Access
Open
Status
Active
Created
Feb-15
This document provides guidance for serialised data exchange between contract manufacturing organisations, third-party manufactures, contract packagers, and the manufacturers who use these partners.
HL7 Arden Syntax for Medical Logic Systems, Edition 3.0
Category
Standard
Organisation
HL7
ID
ARDEN _E3.0_STU_2023DEC
Type
Standard
Version
3
Access
Open
Status
Trial
Created
Dec-23
This standard defines a syntax for creating and sharing computerised health knowledge bases.
HL7 Arden Syntax Implementation Guide, Release 3
Category
Implementation Guide
Organisation
HL7
ID
HL7_IG_ARDEN_R3_INFORM_2020FEB
Type
Standard
Version
3
Access
Open
Status
Active
Created
Feb-20
This implementation guide provides a summary of Arden syntax, as well as ideas and examples related to how the syntax may be best used to address certain clinical applications.
HL7 Business Architecture Model (BAM), Release 1
Category
Informative Document
Organisation
HL7
ID
HL7 BAM_R1_INFORM_2016FEB
Type
Standard
Version
1
Access
Open
Status
Active
Created
Feb-16
This supplementary resource describes a business architecture model for Health Level 7, with an initial focus on product lines and product families.
HL7 CIMI Logical Model for Analysis: Analysis Normal Form (ANF), Release 1
Category
Supplementary Resource
Organisation
HL7
ID
HL7_CIMI_LM_ANF_R1_INFORM_2020JAN
Type
Standard
Version
1
Access
Open
Status
Active
Created
Jan-20
This supplementary resource describes how increasing the precision of clinical information using Analysis Normal Form can enhance and support quality data and analysis and improve patient safety and outcomes.
HL7 Consumer Mobile Health Application Functional Framework (cMHAFF), Release 1
Category
Standard
Organisation
HL7
ID
HL7_CMHAFF_R1_STU2_2023APR
Type
Standard
Version
1
Access
Open
Status
Trial
Created
Apr-23
The Consumer Mobile Health Functional Framework provides a standard to assess a mobile health app’s foundational characteristics against. These characteristics include security, privacy, data access, data export, and transparency and disclosure of conditions.
HL7 Context Management Specification (CCOW), Version 1.6
Category
Specification
Organisation
HL7
ID
HL7 CMS V1.6-2011 (R2016)
Type
Standard
Version
1.6
Access
Open
Status
Superseded
Created
Sep-21
This specification aims to facilitate integration of applications at the point of use. It serves as the basis for ensuring secure and consistent access to patient information from heterogeneous sources.
HL7 Cross Paradigm Specification: Allergy and Intolerance Substance Value Set(s) Definition Release 1
Category
Informative Document
Organisation
HL7
ID
HL7_XPARADIGM_ALLERGY_VS_R1_INFORM_2018AUG
Type
Standard
Version
1
Access
Open
Status
Active
Created
Aug-18
This supplementary resource describes a value set for identifying substances of concern for patients with allergies and intolerances in clinical systems.
HL7 Cross Paradigm Specification: Health Services Reference Architecture (HSRA), Edition 1
Category
Standard
Organisation
HL7
ID
HL7_HSRA_E1_STU_2023SEP
Type
Standard
Version
1
Access
Open
Status
Trial
Created
Sep-23
The Health Services Reference Architecture (HSRA) aims to support the design of medium/large-scale eHealth architectures based on HL7 services and standards.
HL7 Cross-Paradigm Domain Analysis Model: Vital Records, Release 5
Category
Standard
Organisation
HL7
ID
HL7_DAM_VR_R5_STU2_2022MAY
Type
Standard
Version
5
Access
Open
Status
Trial
Created
May-22
The Vital Records Domain Analysis Model states the foundational requirements for the design and development of health information exchange standards in Health Level Seven (HL7) that relate to vital records information flows.
HL7 Cross-Paradigm Implementation Guide: Medical Device Data Sharing, Release 1
Category
Implementation Guide
Organisation
HL7
ID
HL7_XPARADIGM_IG_MEDDEV_R1_INFORM_2020AUG
Type
Standard
Version
1
Access
Open
Status
Active
Created
Aug-20
This implementation guide aims to improve the quality and consistency of medical device data exchanged with enterprise systems (for example, electronic health records, registries and clinical flowsheets).
HL7 Cross-Paradigm Specification: Clinical Quality Language, Release 1
Category
Specification
Organisation
HL7
Type
Standard
Version
1
Access
Open
Status
Active
Created
Dec-20
This specification introduces a high-level, domain-specific language – Clinical Quality Language – focused on clinical quality and targeted at authors of measure and decision support artefacts.
HL7 Cross-Paradigm Specification: FHIRPath, Release 1
Category
Specification
Organisation
HL7
Type
Standard
Version
1
Access
Open
Status
Active
Created
Jul-24
FHIRPath is a path-based navigation and extraction language. Its operations are expressed in terms of the logical content of hierarchical data models, and support traversal, selection and filtering of data.
HL7 Cross-Paradigm Specification: Representing Negatives, Release 1
Category
Informative Document
Organisation
HL7
ID
HL7_XPARADIGM_NEGATION_R1_INFORM_2022APR
Type
Standard
Version
1
Access
Open
Status
Active
Created
Apr-22
This supplementary resource surveys requirements and extant patterns in data specifications for representing negatives, and analyses the relative strengths and challenges of these patterns in different use cases. It aims to identify best practices for specification design and to provide guidance on transforming information among existing specifications.
HL7 Domain Analysis Model: Clinical Sequencing, Release 1
Category
Informative Document
Organisation
HL7
ID
HL7_DAM_CLINSEQ_R1_INFORM_2017FEB
Type
Standard
Version
1
Access
Open
Status
Active
This model should be used to inform standards developers and implementers for the design of scalable, interoperable solutions covering the breadth of clinical genetics/genomics scenarios.
HL7 Domain Analysis Model: Harmonization of Health Quality Artifact Reasoning and Expression Logic, Release 1
Category
Informative Document
Organisation
HL7
ID
HL7_DAM_HARMON_HQAREL_INFORM_R1_2014MAY
Type
Standard
Version
1
Access
Open
Status
Active
Created
May-14
This document defines the common concepts and semantics involved in modelling reasoning within the various aspects of the health quality domain, in particular, quality measurement and clinical decision support.
HL7 Domain Analysis Model: Health Quality Improvement, Release 1
Category
Informative Document
Organisation
HL7
ID
HL7_DAM_HQUAL_R1_INFORM_2014NOV
Type
Standard
Version
1
Access
Open
Status
Active
Created
Nov-14
This document is a conceptual data model that can be used as the basis for a logical data model for the domain of health quality improvement. It harmonises the elements from the existing electronic clinical quality measures (eCQMs) and clinical decision support (CDS) data models into a single, unified conceptual model.
HL7 Version 3 Domain Analysis Model: Immunization, Release 1
Category
Informative Document
Organisation
HL7
ID
HL7_V3_DAM_IZ_R1_INFORM_2012MAY
Type
Standard
Version
1
Access
Open
Status
Active
Created
May-12
This domain analysis model (DAM) incorporates the broad range of areas in public health related to immunisation. It provides a reference for mapping between HL7 immunisation artefacts and supports the needs of the clinical community regarding immunisation.
HL7 Domain Analysis Model: Intra-Procedure Anesthesia, Release 1
Category
Informative Document
Organisation
HL7
ID
HL7_DAM_ANESTH_R1_INFORM_2020NOV
Type
Standard
Version
1
Access
Open
Status
Active
Created
Nov-20
This domain analysis model (DAM) supports the conventional anaesthesia record. It incorporates behavioural and information components.
HL7 Domain Analysis Model: Patient-Centered Care Team, Release 1
Category
Informative Document
Organisation
HL7
ID
HL7_DAM_PCCT_R1_I1_2020MAY
Type
Standard
Version
1
Access
Open
Status
Active
Created
Feb-21
The Patient-centered care team domain analysis model (DAM) captures the roles and relationships of the unique group of individuals who provide care for a single patient. The DAM helps produce standards to improve care and outcomes by creating an interoperable, computable representation of a patient-centred care team.